Manager, Quality Assurance

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

This opportunity is an exciting and challenging role that will be key to Gileads success as we work towards bringing new combination products such as pre-filled syringes and autoinjectors to market. As the Manager Quality Assurance you will be a key Quality person supporting these new product lines in the commercial stage starting with collaborating with the design and development team on Design Transfer. We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products.

Roles and Responsibilities:

• Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve technical issues related drug-device combination product process and quality issues.

• Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation

• Writes and or implement changes to controlled documents (e.g. SOPs Specifications WIs etc.) as needed.

• Create revise execute SOPs to support combination product quality governance during the Design Transfer or in the commercial stage.

• Work with management and department personnel to achieve goals and strategic initiatives.

• Executes changes to quality processes to ensure conformance and continuous improvement.

• Ensure that changes to commercial products are conducted in accordance with FDA QSR/QMSR ISO 13485 and other applicable standards.

• Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards.

• Work cross-functionally with Subject Matter Experts from R&D Clinical and Operations to ensure the risk process is applied comprehensively.

• Participate in annual product reviews and perform periodic review and update of DHF and RMF.

• Review design inputs outputs and verification/validation results.

• Analyze process data and ensure processes are capable and in control.

• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals Medical Devices and Combination Products worldwide.

• Supports due diligence and internal or external audits/inspections as needed.

• Create and provide Quality training as needed for cross functional stake holders and CMOs.

• Support complaints investigations and filter information back to the design and development team and CMOs.

• Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards.

Knowledge Experience & Skills

• Must have 6 years of experience in the medical device industry and a Bachelors degree in science or engineering related field OR 4 years of relevant experience with a Masters degree.

• Demonstrates in-depth knowledge of Quality principles concepts industry practices and standards.

• Previous experience with combination devices is preferred (i.e. Autoinjectors pre-filled syringes).

• Previous experience in Design Transfer to contract manufacturers.

• Quality experience in both clinical and commercial products.

• Well-versed in risk management methodologies and their application.

• Able to work independently and in a global team environment and with all levels of personnel within the organization.

• Possess excellent interpersonal relationship skills.

• Demonstrates understanding of U.S. and international quality systems regulations/standards to adopt best in class systems/processes and drive continuous improvement initiatives.

• Knowledge of ISO 14971 Risk Management tools (e.g. Hazard Analysis / or Failure Mode Effects Analysis (FMEA)) is preferred.

• Certification by ASQ (Certified Quality Auditor Certified Quality Engineer and Certified Quality Manager) or other industry- recognized professional organizations is preferred.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.